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Carcinoma, HepatocellularPhase 2NCT00444782

A Phase II, Open-Label Trial Evaluating GV1001 in Advanced Hepatocellular Carcinoma.

A Phase 2 study testing GV1001 in people with Carcinoma, Hepatocellular, run by Pharmexa A/S at 3 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to investigate the efficacy of GV1001 in locally advanced or metastatic HCC. Also the safety of GV1001 and immunogenicity will be evaluated. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Carcinoma, Hepatocellular
What is being tested?
GV1001
How many people
41 participants
Where
3 sitesin 3 countries
Study dates
Nov 2006to Apr 2008
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Hepatocellular carcinoma diagnosis fulfilling one of the following criteria (as per the American Association for the Study of Liver Diseases [AASLD] guidelines, see Appendix 5):
  • Nodule in a cirrhotic or non-cirrhotic liver with a biopsy showing HCC;
  • Nodule in cirrhotic liver where no biopsy is performed:
  • Nodules between 1-2 cm in a cirrhotic liver with a typical coincidal vascular pattern of HCC (i.e. hypervascular with washout in the portal/venous phase) in two dynamic studies: either CT scan, contrast ultrasound or MRI with contrast.
  • Nodule larger than 2 cm in a cirrhotic liver with a typical vascular pattern of HCC on a dynamic imaging technique.
  • Please note: HCC in a non-cirrhotic liver can only be diagnosed with a biopsy showing HCC.
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  • Measurable disease according to modified RECIST (see Appendix 7).
  • At least one treatment-naïve target lesion (treatment-naïve being defined as not having been treated with local therapy, such as surgery, radiation therapy, hepatic arterial embolisation, chemoembolisation, radio-frequency ablation or cryo-ablation).
  • Barcelona Clinic Liver Cancer (BCLC) stage A, B or C (see Appendix 6) (Stage D is excluded).
  • Child-Pugh stage A (see Appendix 8).
  • Male or female aged 18 years or older.
  • Adequate haematological parameters, as demonstrated by:
  • Haemoglobin greater than or equal to 9.0 g/dL (SI units: 5.6 mmol/L);
  • WBC greater than or equal to 3.0 x 109/L;
  • Platelets greater than or equal to 75 x 109/L.
  • ALT and AST ≤ 5 times the upper limit of normal.
  • Bilirubin < 2 mg/dL.
  • Serum creatinine smaller than or equal to 1.5 mg/dL (SI units: 132 µmol/L).
  • Performance status ECOG 0 or 1.
  • Minimum life expectancy of 3 months at screening.
  • Written informed consent given prior to any study specific procedures.

Who cannot join

  • HCC amenable to curative treatment or transplantation.
  • History of other malignancies in the last 5 years (10 years in the case of breast cancer), except for adequately treated non-melanoma skin cancers (Basal Cell Carcinoma, Squamous Cell Carcinoma) and carcinoma in situ of the cervix.
  • Known history of or co-existing autoimmune disease.
  • Known Central Nervous System (CNS) metastases.
  • Known history of human immunodeficiency virus (HIV).
  • Any medical condition that, in the opinion of the Investigator, may compromise the compliance of the patient to receive study treatment and follow study procedures.
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  • Treatment with any other IMP within 4 weeks prior to cyclophosphamide administration at Day -3.
  • Known sensitivity to any components of cyclophosphamide, GV1001 or GM-CSF.
  • Concomitant treatment with the following within 4 weeks of pre-treatment with cyclophosphamide:
  • Anti-tumour treatment (including radiotherapy, chemotherapy, immunotherapy, endocrine therapy, cytokines, interferons, protease inhibitors, and gene therapy) and vaccines.
  • Chronic corticosteroids (inhaled and topical steroids are permitted including low dose steroids at non-immunosuppressive doses e.g. 15 mg prednisolone daily for up to 7 days).
  • Herbal medicine either containing hypericum perforacum (e.g., St Johns Wort) or claiming to have anti-tumour effects (e.g., Iscador).
  • Pregnancy or lactation.
  • Women of childbearing potential not using reliable and adequate contraceptive methods, defined as the use of oral, implanted, injectable, mechanical or barrier products for the prevention of pregnancy; or women who are practising abstinence; or where the partner is sterile, for example a vasectomy.
  • Unable for any other reason to comply with the protocol (treatment or assessments).

Trial locations and contacts

3 sites in 3 countries.

3 sites in 3 countries

France1 site

  • Michel Beaugrand

    Bondy, 93143

Other trials in France

Germany1 site

  • Tim F. Greten

    Hanover, 30625

Other trials in Germany

Spain1 site

  • Jordi Bruix

    Barcelona, E-08036

Other trials in Spain

About this study

Official title: "Heptovax" - A Phase II, Open-Label Trial Evaluating the Safety and Efficacy of GV1001 in Advanced Hepatocellular Carcinoma.

The purpose of this study is to investigate the efficacy of GV1001 in locally advanced or metastatic HCC. Also the safety of GV1001 and immunogenicity will be evaluated.

Being tested
GV1001
Keywords
Advanced Carcinoma, Hepatocellular
Medical subject headings
Carcinoma, Hepatocellular

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GV1001Biological

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Response rate (Partial and Complete Response) according to modified RECIST.

Secondary outcomes (4)

  1. Time to Progression (TTP)

  2. Time to Symptomatic Progression (TTSP)

  3. Progression Free Survival (PFS)

  4. Immune Response

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Mar 2007 (estimated)
  2. Study startNov 2006
  3. Primary completionApr 2008
  4. Study completionApr 2008

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
41 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00444782
Sponsor's protocol ID
PX115.1.1-201
Status last verified
Dec 2008
First submitted
7 Mar 2007
Last updated
18 Dec 2008
Results posted
No

Publications

  • Greten TF, Forner A, Korangy F, N'Kontchou G, Barget N, Ayuso C, Ormandy LA, Manns MP, Beaugrand M, Bruix J. A phase II open label trial evaluating safety and efficacy of a telomerase peptide vaccination in patients with advanced hepatocellular carcinoma. BMC Cancer. 2010 May 17;10:209. doi: 10.1186/1471-2407-10-209.

    PubMed 20478057

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing GV1001 in people with Carcinoma, Hepatocellular, run by Pharmexa A/S at 3 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 21 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Dec 2008. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in France, Germany, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Response rate (Partial and Complete Response) according to modified RECIST.. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00444782, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2008; AzTrials last refreshed its copy on 4 Nov 2026.

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